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Randomized Trial of Peer Led Education-Project Dulce

This study has been completed.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
San Diego State University
Information provided by:
Scripps Whittier Diabetes Institute
ClinicalTrials.gov Identifier:
NCT01238289
First received: November 8, 2010
Last updated: January 5, 2011
Last verified: November 2010
History of Changes

November 8, 2010
January 5, 2011
September 2006
March 2009   (final data collection date for primary outcome measure)
mean percent change Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 4 months and 10 months ] [ Designated as safety issue: No ]
Evaluate change in HbA1c over a 10 month time period from baseline.
Same as current
Complete list of historical versions of study NCT01238289 on ClinicalTrials.gov Archive Site
Body mass index, blood pressure and lipid changes [ Time Frame: Baseline, 4 months and 10 months ] [ Designated as safety issue: No ]
Evaluate change in Body mass index, blood pressure and lipids over a 10 month time period from baseline
Same as current
Not Provided
Not Provided
 
Randomized Trial of Peer Led Education-Project Dulce
Peer-Led Diabetes Education Programs in High Risk Mexican Americans Evaluates Glycemic Control Compared to Standard Approaches: A Project Dulce™ Promotora Randomized Trial

The purpose of this study is to evaluate the effect of a culturally sensitive diabetes self-management program on glucose control and metabolic parameters in low income Mexican-Americans with type 2 diabetes using the Project Dulce model utilizing a low cost, peer-educator format.

To recruit 207 Mexican-Americans patients from federally-funded community health centers in San Diego County with Hemoglobin A1c (HbA1c) > 8% and randomize to Project Dulce peer intervention or continuation of standard diabetes care. The primary outcome will be the percent change in HbA1c levels at 10 months following randomization.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Diabetes Mellitus, Type 2
  • Behavioral: Peer Education
    Conduct peer education classes for 8 weeks and support groups monthly for a total of 10 months and evaluate effects on metabolic and behavior outcomes
    Other Name: Project Dulce
  • Behavioral: Control
    This group continues with standard care at the community health center
  • Placebo Comparator: Control group
    This arm continues with standard care at community clinic
    Intervention: Behavioral: Control
  • Experimental: Peer Education
    This group receives 8 weeks of peer led self management education classes and subsequent monthly support groups for a total of 10 months
    Intervention: Behavioral: Peer Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
February 2010
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mexican American, men and women, 21-75 years old, who were under-insured patients at federally qualified community health centers in San Diego County with type 2 diabetes and HbA1c > or = 8%.

Exclusion Criteria:

  • Individuals with a physical or mental health condition that would preclude fulfilling the requirements of the study were ineligible to participate, HbA1c < 8,pregnant with gestational diabetes
Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01238289
R18 DK070666-01A1, R18DK070666-01A1
Yes
Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
Scripps Whittier Diabetes Institute
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Center for Research Resources (NCRR)
  • San Diego State University
Principal Investigator: Athena Philis-Tsimikas, MD Scripps Whittier Diabetes Institute
Scripps Whittier Diabetes Institute
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP